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Keywords {🔍}

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Topics {✒️}

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Questions {❓}

• Does the immune system see tumors as foreign or self?
• Prostate stem cell antigen: a Jekyll and Hyde molecule?

Schema {🗺️}

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         headline:Self-adjuvanted mRNA vaccination in advanced prostate cancer patients: a first-in-man phase I/IIa study
         description:CV9103 is a prostate-cancer vaccine containing self-adjuvanted mRNA (RNActive®) encoding the antigens PSA, PSCA, PSMA, and STEAP1. This phase I/IIa study evaluated safety and immunogenicity of CV9103 in patients with advanced castration-resistant prostate-cancer. 44 Patients received up to 5 intra-dermal vaccinations. Three dose levels of total mRNA were tested in Phase I in cohorts of 3–6 patients to determine a recommended dose. In phase II, 32 additional patients were treated at the recommended dose. The primary endpoint was safety and tolerability, the secondary endpoint was induction of antigen specific immune responses monitored at baseline and at weeks 5, 9 and 17. The most frequent adverse events were grade 1/2 injection site erythema, injection site reactions, fatigue, pyrexia, chills and influenza-like illness. Possibly treatment related urinary retention occurred in 3 patients. The recommended dose was 1280 μg. A total of 26/33 evaluable patients treated at 1280 μg developed an immune response, directed against multiple antigens in 15 out of 33 patients. One patient showed a confirmed PSA response. In the subgroup of 36 metastatic patients, the Kaplan-Meier estimate of median overall survival was 31.4 months [95 % CI: 21.2; n.a]. The self-adjuvanted RNActive® vaccine CV9103 was well tolerated and immunogenic. The technology is a versatile, fast and cost-effective platform allowing for creation of vaccines. The follow-up vaccine CV9104 including the additional antigens prostatic acid phosphatase (PAP) and Muc1 is currently being tested in a randomized phase IIb trial to assess the clinical benefit induced by this new vaccination approach. EU Clinical Trials Register: EudraCT number 2008-003967-37 , registered 27 Jan 2009.
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         Cabazitaxel
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         Prostate Stem Cell Antigen
         Tetramer Staining
         Oncology
         Immunology
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               type:PostalAddress
            type:Organization
      email:[email protected]
      name:Ulrike Gnad-Vogt
      affiliation:
            name:CureVac GmbH
            address:
               name:CureVac GmbH, Tuebingen, Germany
               type:PostalAddress
            type:Organization
      name:Kurt Miller
      affiliation:
            name:Charité University Hospital Berlin
            address:
               name:Charité University Hospital Berlin, Berlin, Germany
               type:PostalAddress
            type:Organization
      name:Wolfgang Schultze-Seemann
      affiliation:
            name:University Hospital Freiburg
            address:
               name:University Hospital Freiburg, Freiburg, Germany
               type:PostalAddress
            type:Organization
      name:Frank vom Dorp
      affiliation:
            name:Universitäty Hospital Essen
            address:
               name:Universitäty Hospital Essen, Essen, Germany
               type:PostalAddress
            type:Organization
      name:Giorgio Parmiani
      affiliation:
            name:San Raffaele Scientific Institute
            address:
               name:San Raffaele Scientific Institute, Milan, Italy
               type:PostalAddress
            type:Organization
      name:Christian Hampel
      affiliation:
            name:University Hospital of the Johannes-Gutenberg-University Mainz
            address:
               name:University Hospital of the Johannes-Gutenberg-University Mainz, Mainz, Germany
               type:PostalAddress
            type:Organization
      name:Steffen Wedel
      affiliation:
            name:Ortenau Klinikum Offenburg-Gengenbach
            address:
               name:Ortenau Klinikum Offenburg-Gengenbach, Offenburg, Germany
               type:PostalAddress
            type:Organization
      name:Lutz Trojan
      affiliation:
            name:University Hospital Göttingen, Göttingen/University Hospital Mannheim
            address:
               name:University Hospital Göttingen, Göttingen/University Hospital Mannheim, Mannheim, Germany
               type:PostalAddress
            type:Organization
      name:Dieter Jocham
      affiliation:
            name:University Hospital Schleswig-Holstein Campus Luebeck
            address:
               name:University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany
               type:PostalAddress
            type:Organization
      name:Tobias Maurer
      affiliation:
            name:Klinikum rechts der Isar der Technischen Universität München
            address:
               name:Klinikum rechts der Isar der Technischen Universität München, Munich, Germany
               type:PostalAddress
            type:Organization
      name:Gerd Rippin
      affiliation:
            name:Rippin-Consulting
            address:
               name:Rippin-Consulting, Solingen, Germany
               type:PostalAddress
            type:Organization
      name:Mariola Fotin-Mleczek
      affiliation:
            name:CureVac GmbH
            address:
               name:CureVac GmbH, Tuebingen, Germany
               type:PostalAddress
            type:Organization
      name:Florian von der Mülbe
      affiliation:
            name:CureVac GmbH
            address:
               name:CureVac GmbH, Tuebingen, Germany
               type:PostalAddress
            type:Organization
      name:Jochen Probst
      affiliation:
            name:CureVac GmbH
            address:
               name:CureVac GmbH, Tuebingen, Germany
               type:PostalAddress
            type:Organization
      name:Ingmar Hoerr
      affiliation:
            name:CureVac GmbH
            address:
               name:CureVac GmbH, Tuebingen, Germany
               type:PostalAddress
            type:Organization
      name:Karl-Josef Kallen
      affiliation:
            name:CureVac GmbH
            address:
               name:CureVac GmbH, Tuebingen, Germany
               type:PostalAddress
            type:Organization
      name:Thomas Lander
      affiliation:
            name:CureVac GmbH
            address:
               name:CureVac GmbH, Tuebingen, Germany
               type:PostalAddress
            type:Organization
      name:Arnulf Stenzl
      affiliation:
            name:University Hospital Tuebingen
            address:
               name:University Hospital Tuebingen, Tuebingen, Germany
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Klinikum rechts der Isar der Technischen Universität München, Munich, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:Charité University Hospital Berlin, Berlin, Germany
      name:University Hospital Freiburg, Freiburg, Germany
      name:Universitäty Hospital Essen, Essen, Germany
      name:San Raffaele Scientific Institute, Milan, Italy
      name:University Hospital of the Johannes-Gutenberg-University Mainz, Mainz, Germany
      name:Ortenau Klinikum Offenburg-Gengenbach, Offenburg, Germany
      name:University Hospital Göttingen, Göttingen/University Hospital Mannheim, Mannheim, Germany
      name:University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany
      name:Klinikum rechts der Isar der Technischen Universität München, Munich, Germany
      name:Rippin-Consulting, Solingen, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:CureVac GmbH, Tuebingen, Germany
      name:University Hospital Tuebingen, Tuebingen, Germany

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